Recall Z-2496-2025 ยท NDC Calculator, Drug Dose
Medtronic MiniMed, Inc.
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
| Date | Sep 2, 2025 (initiated Jun 16, 2025) |
| Status | Open, Classified |
| Reason | Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been rep |
| Root cause | Under Investigation by firm |
| Action | On 6/16/2025, correction notices were emailed to customers who were asked to do the following: Actions Required: Users of InPen app software should update to version 7.5.1 or higher. For iOS Users - Verify your app version: - On the home screen, navigate to the Settings menu (lower right corner). - Select Help and Support. - Note the App Version displayed. - Open the App Store. - Tap your profile icon at the top of the screen. - Scroll to see pending updates. - Tap Update next to the InPen app icon. For Android Users - Verify your app version: - On the home screen, navigate to the Settings |
| Quantity | 6816 |
| Distribution | International distribution to the countries of Argentina, Australia, Austria, Belgium, Bermuda, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Luxembourg, Netherlands, New Zealand, Norway, Poland, Portugal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) Medtronic Minimed, Nov 12, 2024 |